Analyte sensor devices, connections, and methods

ABSTRACT

Devices associated with on-body analyte sensor units are disclosed. These devices include any of packaging and/or loading systems, applicators and elements of the on-body sensor units themselves. Also, various approaches to connecting electrochemical analyte sensors to and/or within associated on-body analyte sensor units are disclosed. The connector approaches variously involve the use of unique sensor and ancillary element arrangements to facilitate assembly of separate electronics assemblies and sensor elements that are kept apart until the end user brings them together.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/951,629, filed Nov. 18, 2020, which is a continuation ofU.S. patent application Ser. No. 15/908,616, filed Feb. 28, 2018, whichis a continuation of U.S. patent application Ser. No. 15/610,334, filedMay 31, 2017, now U.S. Pat. No. 9,931,066, which is a continuation ofU.S. patent application Ser. No. 15/193,499, filed Jun. 27, 2016, nowU.S. Pat. No. 9,693,713, which is a continuation of U.S. patentapplication Ser. No. 13/710,460, filed Dec. 11, 2012, now U.S. Pat. No.9,402,570, which claims priority to U.S. Provisional Application No.61/569,287, filed Dec. 11, 2011, all of which are incorporated herein byreference in their entireties for all purposes.

BACKGROUND

Diabetes Mellitus is an incurable chronic disease in which the body doesnot produce or properly utilize insulin. Insulin is a hormone producedby the pancreas that regulates blood sugar (glucose). In particular,when blood sugar levels rise, e.g., after a meal, insulin lowers theblood sugar levels by facilitating blood glucose to move from the bloodinto the body cells. Thus, when the pancreas does not produce sufficientinsulin (a condition known as Type 1 Diabetes) or does not properlyutilize insulin (a condition known as Type II Diabetes), the bloodglucose remains in the blood resulting in hyperglycemia or abnormallyhigh blood sugar levels.

The vast and uncontrolled fluctuations in blood glucose levels in peoplesuffering from diabetes cause long-term, serious complications. Some ofthese complications include blindness, kidney failure, and nerve damage.Additionally, it is known that diabetes is a factor in acceleratingcardiovascular diseases such as atherosclerosis (hardening of thearteries), leading to stroke, coronary heart disease, and otherdiseases. Accordingly, one important and universal strategy in managingdiabetes is to control blood glucose levels.

One element of managing blood glucose levels is the monitoring of bloodglucose levels. Conventional in vitro techniques, such as drawing bloodsamples, applying the blood to a test strip, and determining the bloodglucose level using colorimetric, electrochemical, or photometric testmeters, may be employed. Another technique for monitoring glucose levelsuses an in vivo analyte monitoring system, which measures and storessensor data representative of glucose levels automatically over time.

Unlike conventional in vitro blood glucose monitoring approaches, invivo analyte monitoring systems use an insertable or implantable in vivosensor that is positioned to be in contact with interstitial fluid of auser for a period of time to detect and monitor glucose levels. Prior touse of an in vivo sensor, at least a portion of the sensor is positionedunder the skin. An applicator assembly can be employed to insert thesensor into the body of the user. For insertion of the sensor, a sharpengaged with the sensor, pierces the skin of the user and is thenremoved from the body of the user leaving the sensor in place. The invivo-positioned sensor can be connected to other system components suchas sensor electronics contained in a unit that can be held onto theskin.

To realize fully the advantages associated with such systems, what isneeded are applicator systems configured to handle insertion, as well aspackaging and user interface issues, that are easy-to-use, reliable andminimize both user inconvenience and pain. The present inventionprovides such solutions and additional or alternative advantages asdescribed below and/or as may be appreciated by those of skill in theart upon review of the subject disclosure.

SUMMARY

The present invention includes packaging, loading systems, applicators,and elements of the on-body devices themselves. According to embodimentsof the present invention, an on-body device includes an electronicsassembly and a sensor assembly. The sensor assembly includes a sensorand a connector for coupling the sensor to the electronics assembly. Inaddition, a sharp can be provided that supports the sensor and allows adistal end of the sensor to be placed under a user's skin. In someembodiments, the invention includes the connection of electrochemicalanalyte sensors to and/or within associated other monitoring componentssuch as system devices that are configured to be held in place on body.The approaches variously involve the use of unique sensor and uniqueancillary element arrangements to facilitate assembly of separateon-body devices and sensor assembly units that are kept apart until theuser brings them together. Methods associated with such use also formpart of the inventive subject matter.

Certain embodiments are described that include an analyte sensor (e.g.,a glucose sensor) and an applicator assembly to position a portion ofthe sensor beneath a skin surface, as well as methods of positioning atleast a portion of the sensor and methods of analyte testing ormonitoring. Further methods include the manner of preparing theapplicator assembly. Namely, such acts associated with user assembly andmating of the component parts of a monitoring system.

As mentioned above, such a monitoring system includes an electronicsassembly adapted to adhere to a skin of a subject, a sensor assemblycoupled to the electronics assembly to form an on-body device, and aninsertion sharp having a longitudinal body including a longitudinalopening to receive at least a portion of the sensor body. The details ofthe sensor may vary. Exemplary chemistries and constructions aredescribed in any of U.S. Pat. Nos. 5,593,852, 6,284,478, and 6,329,161,each incorporated by reference herein in its entirety. Exemplaryform-factors or configurations (e.g., for associated use with aninsertion “sharp”) are described in any of U.S. Pat. Nos. 6,175,752,6,565,509, 6,134,461 and 6,990,366 and in U.S. Publication No.2010/0230285, each incorporated by reference herein in its entirety.

Likewise, the details of the on-body device may vary. For instance, theon-body device may include sensor electronics and other adaptation tocommunicate with a monitoring device. Various options for communicationsfacilities (e.g., wireless transmitters, transponders, etc.) aredescribed in detail in U.S. Patent Publication Nos. 2010/0198034 and2011/0213225, the entirety of the applications hereby incorporated byreference, including cited and incorporated references.

In some embodiments, systems and methods are provided for assembling andapplying the on-body device including assembling the sensor assembly tothe electronics assembly and inserting a portion of the sensor under theskin of a user. Thus, the sensor assembly includes a sensor that has adistal portion for operative contact with a fluid of the user. Theon-body device also includes an electronics assembly including a housingdefining a distal surface adapted for attachment to the skin of the userand a circuit coupleable to the sensor for detecting electrical signalsfrom the sensor. In some embodiments, the system also includes anapplicator assembly that has a sleeve defining a distal surface forplacement on the skin of the subject, a handle for a user interface, andvarious internal support, coupling, guide, grasping, stop and detentfeatures as well as driver elements. In some embodiments, the system mayalso include a container that stores one or more of the sensor, thesharp, and/or the mount/electronics assembly in a sealed environmentwithin. The container is configured to releasably interface with theapplicator assembly for the purpose of loading one or more of thesensor, the sharp, and/or the electronics assembly into the applicatorassembly, and readying the applicator assembly for use.

The present disclosure includes the subject systems, devices, kits inwhich they are included, and methods of use and manufacture. A number ofaspects of such manufacture are discussed herein. Further details can beappreciated in reference to the figures and/or associated description.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description of various aspects, features, and embodiments ofthe subject matter described herein is provided with reference to theaccompanying drawings, which are briefly described below. The drawingsare illustrative and may or may not be drawn to scale, with thepossibility of some components and features being exaggerated forclarity. Similar components may be numbered identically or not. Thedrawings illustrate various aspects and features of the present subjectmatter and may illustrate one or more embodiment(s) or example(s) of thepresent subject matter in whole or in part.

FIG. 1 is a flowchart, indicating user activity in handling the subjectdevices;

FIGS. 2A-2G illustrate such activity with additional detail;

FIG. 3 is an assembly view of an applicator or inserter;

FIG. 4 is an assembly view of a sensor container or loader;

FIGS. 5A and 5B are section views of the container in FIG. 4;

FIG. 6 is an assembly view of an alternative container;

FIG. 7 is a section view of the assembly of FIG. 6;

FIG. 8 is an assembly view of yet another sensor container set orloader;

FIGS. 9A and 9B are top and section views, respectively, of thecontainer set assembly of FIG. 8 in stages of operation;

FIGS. 10A-10N variously illustrate the mechanics of preparing theapplicator for use;

FIGS. 11A-11F illustrate the mechanics of applicator use;

FIGS. 12A-12D are perspectives illustrating another applicator/containerset approach in which the container holds the electronics assembly;

FIGS. 13A-13C variously illustrate use of the applicator in FIGS.12A-12D in connection with a locking-sleeve feature;

FIGS. 14A and 14B illustrate an applicator with a removable lockingstrip;

FIGS. 15A-15F variously illustrate use of the applicator in FIGS. 14Aand 14B;

FIGS. 16A and 16B are sectional and detail to views, respectively, offeatures of the container in FIGS. 15A-15D;

FIGS. 17A and 17B are perspective assembly views illustratingalternative container configurations to that illustrated in FIGS. 16Aand 16B;

FIG. 18 is a side-section view illustrating the features of theapplicator and container sets variously shown in FIGS. 15A-15F;

FIGS. 19A and 19B are perspective views of a sensor assemblyincorporated in the system shown in FIG. 18;

FIGS. 20A and 20B are perspective views of the operation of a sensorassembly retention unit incorporated in the system shown in FIG. 18;

FIGS. 21A-21C are perspective section views illustrating sensor assemblyreceipt by the sensor mount and sharp withdrawal from the assembledcomplex;

FIG. 22 is a perspective assembly view of advantageous sensor and sensorconnector elements;

FIGS. 23A and 23B are perspective assembly and final-assembly views,respectively of the sensor components in FIG. 22;

FIGS. 24A and 24B are top and bottom perspective views, respectively ofcircuit board components to be used with the assembly shown in FIGS. 23Aand 23B;

FIGS. 25A and 25B are perspective views illustrating assembly of thesubject components in stages;

FIG. 26 is an assembly view of the on-body/sensor mount unit in FIGS.25A and 25B illustrating an advantageous seal element;

FIGS. 27A and 27B are section views further illustrating the sealelement and its relation to the mount in FIG. 26;

FIGS. 28A-F are perspective views of another advantageous sensor andsensor element arrangement;

FIGS. 29A-D are perspective views of another advantageous sensor andsensor connector arrangement;

FIGS. 30A-30B are perspective views illustrating yet anotheradvantageous sensor approach with the sensor as originally produced andmodified for use, respectively;

FIG. 30C is a perspective view illustrating the sensor as configured inFIGS. 30A and 30B coupled to a PCB;

FIG. 31 is a side-section view showing a comparative approach, in afinal on-body sensor assembly;

FIGS. 32A and 32B are perspective views of still other advantageoussensor configurations, these figures illustrating split-sensorapproaches;

FIGS. 33A-33G are plane, side, magnified, and sectional views of anadditional sensor configuration;

FIGS. 33H-33J are plane views of various sensor designs;

FIGS. 34A-34D are perspective views illustrating combination electricalconnector and sensor isolator in yet another advantageous sensorarrangement;

FIGS. 35A and 35B are side assembly and section views, respectively, ofthe system shown in FIGS. 34A-34D;

FIG. 35C is an end-section view, with detail view, FIG. 35D,illustrating additional sensor features;

FIG. 36 is a perspective assembly view illustrating a sensor connectionapproach related to that in FIGS. 34A-34D for a sensor with contacts ona single side;

FIG. 37 is a perspective partial assembly view illustrating amount-and-socket interface for the sensor assembly employing thecomponents in FIG. 36;

FIG. 38 is a complete assembly view of that illustrated in FIG. 37;

FIGS. 39A and 39B are perspective assembly and as-assembled views of astacked non-directional sensor connect arrangement;

FIG. 40 is a side partial-sectional view of the sensor in FIG. 39received within an on-body device;

FIGS. 41A and 41B are partial perspective assembly views of anotherstacked non-directional sensor connection arrangement;

FIG. 41C is a section view of the complete assembly of the componentsvariously illustrated in FIGS. 41A and 41B;

FIG. 42 is an assembly view of an advantageous radial arrangement sensorconnector assembly;

FIGS. 43A and 43B are reversed perspective views of the mount-sidesensor connection component for use with an assembly as shown in FIG.42;

FIG. 44 is a section view of the complete assembly of the componentsvariously illustrated in FIGS. 42, 43A and 43B;

FIGS. 45A and 45B are reversed assembly views of an alternativeadvantageous sensor connection assembly that can be used like that inFIG. 42;

FIGS. 46A and 46B are assembly and sectional views, respectively of acomplete on-body device employing the sensor and connection elementsillustrated in FIGS. 45A and 45B;

FIG. 47A-47C are assembly and cross-sectional views of an on-body deviceincluding an integrated connector for the sensor assembly;

FIGS. 48A-48D are construction views of an on-body subassembly;

FIG. 48E is a perspective view of a complete on-body electronicssubassembly;

FIGS. 49A-49D illustrate the process of co-molding/overmolding theassembly in FIG. 48E;

FIGS. 50A-50C are assembly and sectional views of an alternativesnap-together approach with the assembly in FIG. 48E; and

FIGS. 51A-51B are assembly views illustrating adhesive backingapplication in producing a final on-body device ready for use as shownin perspective-view FIG. 51C.

DETAILED DESCRIPTION

Before the present disclosure is further described, it is to beunderstood that this disclosure is not limited to the particularembodiments described, as such may, of course, vary. It is also to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting, since the scope of the present disclosure will be limited onlyby the appended claims.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein includes discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentdisclosure.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the disclosure. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges, and are also encompassed within the disclosure, subjectto any specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the disclosure.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosure belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present disclosure, exemplarymethods and materials are now described. All publications mentionedherein are incorporated herein by reference to disclose and describe themethods and/or materials in connection with which the publications arecited.

As used herein and in the appended claims, the singular forms “a,” “an,”and “the” include plural referents unless the context clearly dictatesotherwise. It is further noted that the claims may be drafted to excludeany optional element. As such, this statement is intended to serve asantecedent basis for use of such exclusive terminology as “solely,”“only” and the like in connection with the recitation of claim elements,or use of a “negative” limitation.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present disclosure isnot entitled to antedate such publication by virtue of prior disclosure.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.

Various exemplary embodiments of the disclosure are described below.Reference is made to these examples in a non-limiting sense. They areprovided to illustrate more broadly applicable aspects of the presentdisclosure. Various changes may be made to the disclosure described andequivalents may be substituted without departing from the true spiritand scope of the disclosure. In addition, many modifications may be madeto adapt a particular situation, material, composition of matter,process, process act(s) or step(s) to the objective(s), spirit or scopeof the present disclosure. All such modifications are intended to bewithin the scope of the claims made herein.

Applicator and Container Overview

Turning to FIG. 1, a flowchart depicting an example method 100 of usingvarious systems of the present invention is provided. In someembodiments, a user starts with unpacking the container (102) andunpacking the applicator (104). Unpacking the container (102) caninclude removing a cover that provides a sterile seal to the containercontents and unpacking the applicator (104) can include removing an endcap that provides a sterile seal to the internal portion of theapplicator. Next, in an assembly operation (106), the applicator isinserted into the container to merge or connect the sensor assembly andthe electronics assembly together to form an on-body device and aninsertion needle or sharp. In some embodiments, the user unlocks theapplicator or removes a locking element to ready the applicator for use.The process of the assembly operation (106) and the constituentcomponents are described in detail below.

Next, once the user has chosen an application site, an on-body deviceapplication operation (108) is performed. In the application operation(108), the user places the applicator on the skin of the insertion siteand then applies a force to install the on-body device. The applicatoris driven to insert the distal end of the sensor through the user'sskin, adhere the on-body device to the skin surface, and retract thesharp into the applicator for disposal. In some embodiments, the userperforms the application operation (108) by applying force to theapplicator where the force applied is a single, continuous pushingmotion along the longitudinal axis of the applicator that once started,causes the applicator to perform the application operation (108) suchthat the applicator does not stop operation until completion. Theapplicator is configured to relay action/audible cues to the user sothat all three of the above listed actions happen automatically inresponse to applying the force to the applicator causing it to trigger.Advantageously, an adhesive of the on-body device does not contact theuser until the application operation (108) is performed. So, the evenafter the applicator has been placed on the skin, the applicator can bemoved to a different location up until the application operation (108)is performed without damage to the apparatus or other system components.In a post application stage (110), use of the sensor for monitoring theuser's analyte level occurs during wear followed by appropriatedisposal.

Details of method 100 are illustrated in the sequence of drawings shownin FIGS. 2A to 2G. In FIG. 2A, one of the highlighted application sites202, 204 on a user 200 is selected. In some embodiments, otherapplication sites may be used. In some embodiments, a site preparationoperation may optionally be performed. The application site 202, 204 maybe shaved, exfoliated, cleaned, or otherwise treated to better adherethe on-body device. More specifically, the skin at the site of theuser's body where the on-body device will be adhered may be prepared toreceive the on-body device. For example, the skin may be shaved with arazor, cleaned with isopropyl alcohol (IPA), and exfoliated with anabrasive. A mechanically exfoliating element can be used to remove anouter layer of dead skin and expose newer skin below. These elementsinclude: microfiber exfoliating cloths; pumice or other abrasivemineral; metal-stamped components of a rasp/file type configuration;synthetic scouring material, e.g., Scotch-Brite®; an alternate adhesivetape or patch to be applied and stripped off to remove dead skin; andorganic abrasive elements such as salt, crushed almond shells, apricotkernels, etc. Likewise, a chemically exfoliating element may be used toprepare the site, including: mild acids such as alpha hydroxyl acid,beta-hydroxyl acid and salicylic acid; and fruit enzymes. Suchchemically abrasive element(s) may be incorporated in a preparation pad,towelette, swab or be supplied otherwise. In some embodiments, the endcap of the applicator may include one or more exfoliating elements. Insome embodiments, the end cap may be textured or otherwise formed toprovide a surface that can be used to exfoliate the skin of the sitewhere the on-body device will be adhered. Exfoliating away an outerlayer of dead skin before application may allow the on-body device tobetter adhere to the skin for a longer period of time.

FIG. 2B illustrates loader or container 206 preparation, includingremoving cover 208 from a casing 210. The container 206 includes thecasing 210 which holds the sensor assembly and a sharp (or in someembodiments, the electronics assembly). FIG. 2C illustrates applicator212 preparation including separating a removable applicator end cap 214from applicator assembly 216. In some embodiments, container 206 andapplicator 212 can initially be packaged connected together to simplifypackaging and shipping. For example, the removable applicator end cap214 may include a boss or other feature that couples or snaps to acorresponding feature on the exterior of the container 206. Thisconnection is only operative to hold the two pieces together forshipping purposes and not for operation of the system. Thus, in someembodiments, before removing the cover 208 from the casing 210 andseparating the removable end cap 214 from the applicator assembly 216,in an initial unpacking step, the container 206 and applicator 212 areseparated from each other.

As shown in FIG. 2D, once alignment indicators 218, 220 are aligned, theuser assembly operation 106 (FIG. 1) is achieved by pushing theapplicator assembly 216 firmly into the container 206 to retrieve asensor and a sharp from the container and to unlock a guide sleeve ofthe applicator assembly 216. In FIG. 2E, the assembled and unlockedapplicator assembly 216 is placed on the application site 204 (or 202)and pushed down firmly to effect on-body device application 108 (FIG.1). As shown in FIG. 2F, upon used applicator assembly 216 removal fromthe application site 204, on-body device 222 is adhered to the user. Insome embodiments, as illustrated in FIG. 2G, analyte levels detected bythe sensor of the on-body device 222 can be retrieved over a wirelesscommunication link 224 via a communications facility (e.g., atransmitter, a transponder, etc.) within the on-body device 222 by areceiver unit 226 (referred to alternatively as a “reader unit” or“receiver device”, or in some contexts, depending on the usage, as a“display unit,” “handheld unit,” or “meter”). Relevant information(e.g., analyte level trend data, graphs, etc.) is presented on thereceiver unit's display 228.

The applicator 212, container 206, and associated components shown inFIGS. 2A to 2G are illustrated in more detail in FIGS. 3 and 4. Inaddition, numerous other variations are described in detail below. Thesealternative embodiments may operate differently insofar as theirinternal workings, but may present no difference concerning useractivity.

Turning to FIG. 3, applicator 212 includes a removable cap 214 andapplicator assembly 216. The removable cap 214 can be secured to theapplicator assembly 216 via complimentary threadings 306, 306′. End Cap214 fits with the applicator 216 to create a sterile packaging forinterior of the applicator 216. Therefore, no additional packaging isrequired to maintain sterility of the interior of the applicator 216. Insome embodiments, the end (not visible) of the removable end cap 214 caninclude one or more openings, which can be sealed by a sterile barriermaterial such as DuPont™ Tyvek®, or other suitable material, to formseal 308. Such provision allows for ethylene oxide (ETO) sterilizationof the applicator 212 through the seal 308 when closed. In someembodiments, the openings in the removable cap 214 may not be presentand the removable cap 214 may be made from a sterile process-permeablematerial so that the interior of the applicator can be sterilized whenthe cap is mated to it, but that maintains sterility of the interior ofthe cap after exposure to the sterility process. In some embodiments,ETO sterilization is compatible with the electronics within theelectronics assembly 310 and with the associated adhesive patch 312,both of which can be releasably retained within the applicator assembly216 until applied to the user. As shown, the applicator assembly 216includes a housing 314 including integrally formed grip features 316 anda translating sheath or guide sleeve 318.

In reference to FIG. 4, the container 206 includes a cover 402 (e.g.,made of a removable material such as foil) and casing 404. Housed withinthe casing 404 is a desiccant body 412 and a table or platform 408. Insome embodiments, the desiccant body 412 can have an annular shape sothat the desiccant body 412 can be disposed within the casing 404 and asensor assembly support (not visible in FIG. 4 but see 512 in FIGS. 5Aand 5B) can extend up through the desiccant body 412. This arrangementallows the container 206 to include a desiccant without requiring anyadditional height to accommodate the desiccant. A sensor assembly 410 issnap-fit or otherwise held by the sensor assembly support 512. Thesensor assembly 410 can also be snap-fit or otherwise held by theplatform 408 (e.g., using fingers 414). With the cover 402 sealed, thecontainer 206 can be subjected to gamma or radiation (e.g., e-beam)sterilization, an approach compatible with the chemistry of the sensorincluded in the sensor assembly 410. Like the applicator 212, thecontainer 206 is its own sterile packaging so that no additionalpackaging, other than the casing 404 and the cover 402, is required tomaintain sterility of the interior of the casing.

The container 206 and the applicator 212 may be sterilized by differentsterilization approaches. For example, a sensor contained in a container206 may require one type of sterilization process and the contents of anapplicator 212—for example, electronics contained within the interior ofthe applicator 212—may require another type of sterilization process.The utility of a two-piece separable but combinable system (i.e., thecontainer 206 and the applicator 212) enables the respectivesterilization of the two pieces and sterility maintenance before the twoare connected together for use. In other words, separately sealing thecontainer 206 and the applicator 212 facilitates the use of otherwiseincompatible sterilization methods for these two components. Forexample, one type of sterilization which could damage the chemistry ofthe sensor can be used to sterilize the applicator 212 including theelectronics assembly 310 including the adhesive patch 312. Likewise,another sterilization process which could damage the electronics in theelectronics assembly 310 (and/or the adhesive patch 312 used to adherethe electronics assembly 310 to the user's skin) can be used tosterilize the container 206 including the sensor therein. Still otheradvantages may exist, given different shelf-life attributes for theactive (i.e., electronic, chemical, etc.) elements. In some embodiments,all components can be sterilized using the same sterilization technique,such as, but not limited to ETO and e-beam sterilization, etc.

In some embodiments, the platform 408 in the container 206 functions asan anti-tamper barrier for the sensor assembly 410 and prevents directhandling of the sensor assembly 410 by the user. More specifically, theplatform 408 is disposed to protect and assist in the retention of thesensor, a sharp, and an associated connector. In some embodiments, theplatform 408 is locked in place within the casing 404 until released bya longitudinally directed force from the applicator assembly 216 duringthe user assembly operation 106 (FIG. 1). In other words, as the guidesleeve 318 of the applicator assembly 216 is inserted down against theplatform 408, the sleeve 318 releases a locking mechanism (e.g., acatch) and allows the platform to translate deeper into the casing 404.Additionally, features of the casing 404 can be employed to unlock aguide sleeve lock feature of the applicator assembly 216. In someembodiments, the platform 408 in the container 206 can only be unlockedif the guide sleeve 318 of the applicator assembly 216 is inserted intothe container 206 with alignment marks on the applicator assembly 216and the container 206 properly aligned. (See FIG. 10C and associatedtext below).

FIG. 5A is an isometric, cross-sectional view of the casing 404 of FIG.4. FIG. 5B is an assembled, isometric, cross-sectional view of thecontainer 206 of FIG. 4 including the component parts. As can be seen inFIGS. 5A and 5B, platform 408 is surrounded by multiple locking features502 (at least one is advantageously provided in some embodiments). Eachof locking features 502 includes a cantilevered arm 504 with a tongue506 received in a slot or groove 508. So disposed, the platform 408 islocked in place. When the arm(s) 504 are urged inward, in the directionrepresented by arrows P and P′, from a concentrically disposed sleeve318 (not shown) of the applicator assembly 216 riding over ramp(s) 510,the locking feature(s) 502 are released and the platform 408 cantranslate in direction B along a longitudinal axis of the combinedapplicator assembly 216 interfaced with the container 206. Thetranslation of the platform 408 into the casing 404 provides access tosensor assembly 410 by the applicator assembly 216. Until the platform408 is unlocked and driven down into the casing 404, the sensor assembly410 is otherwise isolated from being touched or otherwisehandled/accessed by a user. In some embodiments, additional detent rampfeatures can be provided to hold the platform 408 until depressed withforce applied by a user. In addition, various key-and-way orslot-and-groove guidance features can be provided to control such motionand ensure that it is smooth and linear (i.e., to avoid platformcanting, binding, etc.)

In some embodiments, the sleeve/ramp interface with associated locksrelies only on detent features to maintain the platform's position. Soconfigured, inadvertent handling of the sensor assembly can be avoided.The detent(s) can be tuned to require deliberate action to clear theplatform 408.

In some embodiments, alternative mechanisms and arrangements may beemployed to provide a platform 408 that collapses upon application offorce via the applicator assembly 216 by the user. For example, FIGS. 6and 7 depict an alternative container 600 embodiment including analternative platform 602 arrangement. Here, a collapsible armature orlinkage 604 supports the platform 602. This linkage 604 is integrallyguided and spring-loaded by virtue of the living hinge design of thelinkage 604. Alternatively, a coil spring could be employed along withguides for the platform 602. A sleeve 318 (FIG. 3) (FIG. 3) of anapplicator 216 or the base of sensor mount unit 606 itself, can be usedto translate the platform 602 to provide clearance for sensor assembly608 access and pick-up by the applicator 216 and incorporation as acomplete assembled on-body device 222. The container 600 includes acasing 610 and can also include a desiccant ring 612 to protect thesensor assembly 608 from moisture.

Another embodiment for sensor storage and protection is illustrated inFIG. 8 with container 800. As with the prior embodiments, thisembodiment can also include an annular desiccant ring 612. Casing 802 isprovided in connection with a support base 804. The support base 804receives sensor assembly 608 and a frame 806. The frame 806 includes apivoting door 808. As shown, the support base 804 incorporates threechannels 810 for receipt of frame legs 812 to serve as guidance. In itsup/closed position shown in FIG. 9A, door 808 protects the sensorassembly 608 from contact by the user. Spiral ramp features interactingbetween the support base 804 and the frame 806 cause the door 808 toswing open as the frame 806 is moved down as shown in FIG. 9B. Likewise,features of the frame 806 can hold the sensor assembly 608 against thesupport base 804 until the frame 806 is pushed down by user activity.

Similar to the container embodiment 206 shown in FIGS. 5A and 5B, theframe 806 in container 800 can be locked in place and released byapplicator sleeve introduction. A support ring 902 may lock against bossor tang 814 until the boss 814 is urged inward by the action of anapplicator sleeve along angled interface surface 904 of each leg 812. Insome embodiments, the legs 812 can be biased outward with a preload butin other embodiments, the locking/unlocking function can operate withoutsuch biasing. FIG. 9A illustrates the locked configuration, whereas FIG.9B illustrates unlocked/translated relation of components.

FIGS. 10A to 10N illustrate example details of embodiments of theinternal device mechanics of preparing the applicator 212 for use, usingthe container 206. All together, these drawings represent an examplesequence of assembling an on-body device 222 by connecting a sensorassembly 410 stored in the container 206 with an electronics assembly310 stored in the applicator 212. In addition, the sequence prepares theapplicator 212 to apply the assembled on-body device 222 to the user.Modification of such activity for use with the alternative containerembodiments (as described above or others) can be appreciated inreference to the same by those with skill in the art.

FIGS. 10A and 10B show container 206 and applicator 212 with theirconstituent parts, along with arrows indicating the manner of cover 402and cap 214 removal, respectively. Upon peeling off foil cover 402 fromthe casing 404, the platform 408 within is locked, thus protecting thesensor assembly 410 (not visible but see FIG. 4) which includes asensor, a sensor support (also referred to as a plug), a connector, anda sharp. (These components are discussed in detail below.) Likewise,upon removal of cap 214 from the applicator assembly 216, the applicator212 is locked. As a result of being locked, a guide sleeve 318 (notvisible but see FIG. 3) cannot be collapsed into the applicator'shousing 314.

In FIG. 10C, applicator assembly 216 is set within container 206. Thetwo components 206, 216 are rotated and advanced until mechanicalalignment features M and M′ engage, allowing the applicator assembly 216to register and sit level within the container 206. Visual alignmentindicators A and A′ assist or guide the user to quickly find the properalignment position. Note that in some embodiments, the platform 408cannot be unlocked to translate into the container 206 unless thealignment features M and M′ are properly aligned. FIG. 10D depicts thecomponents 206, 216 with the mechanical alignment features M, M′engaged. Sleeve 318 passes over platform 408, with the platform 408nested concentrically inside the inner diameter of sleeve 318.

Cross-sectional views FIGS. 10E and 10F illustrate the relationship ofparts overviewed in FIGS. 10C and 10D. When the sleeve 318 of applicatorassembly 216 is seated onto the platform 408 of the container 206 andpushed downward, platform locking features 502 disposed around theplatform 408 on locking ribs 1002 are unlocked to allow the platform 408to translate along a longitudinal axis (labeled “Z”) of the interfacedcomponents 206, 216. More specifically, a portion of platform 408 bendsand platform locking arms 504 are displaced inward as indicated by arrowP to clear locking grooves 508 in the locking ribs 1002 of casing 404,thus unlocking the platform 408. At this point, the platform 408 is heldin place by guide ribs 1004 each providing a detent feature 1006 betweenthe platform 408 and the guide ribs 1004 that can be overcome by furtherdownward pressure applied by the user upon further depression of theapplicator assembly 216 in the direction of the longitudinal axis Z.

Turning now to FIGS. 10G and 10H, the dropping of the unlocked platform418 is illustrated. FIG. 10G depicts further depression of theapplicator assembly 216 in the direction of the longitudinal axis Z. Theforce from the sleeve 318 causes inward, radial deflection of a portionof the platform 408. The effect is that detent arms 1008 are flexeddown, inward and away from the detent feature 1006 of guide ribs 1004 asshown. This action releases the platform 418 and the applicator assembly216 into freefall into the container 206. In some embodiments, the forceto flex detent arms 1008, or in other words, the force to overcome theresistance from the detent features 1006, is selected to create apredetermined amount of momentum sufficient to ultimately properly matethe electronics assembly 310 with the sensor assembly 410 and unlock thesleeve 318. In some embodiments, the force to overcome the resistancefrom the detent features 1006 is from approximately 1 N to approximately23 N. Other practicable values are possible.

In FIG. 10H, once detent arms 1008 of the platform 418 are past thedetent features 1006, a relieve or undercut 1010 in each of the guideribs 1004 provides increased clearance for the platform 418 to reducesliding friction as the sleeve 318 and platform 418 slide or telescopefurther into the container's casing 404 along the longitudinal axis Z(FIG. 10F). Also, one or more flexible grasping arms 1012 previously incontact with the sensor assembly 410, particularly through sharp boss1014, are moved from a stabilizing configuration in FIG. 10G to a freedstate or configuration in FIG. 10H. In other words, as the platform 418translates further into the container 206, the sharp boss 1014 of thesensor assembly 410 protrudes through a central opening in the platform418 and pushes the flexible grasping arms 1012 out of the way.

Turning now to FIGS. 10I and 10J, a cross-sectional view depicting aslightly different cut plane than the prior views is provided toillustrate additional features. In FIG. 10I, sleeve lock arms are shownengaged with a sleeve lock ledge 1018. This engagement locks theapplicator assembly 216 and prevents the sleeve 318 from being able tobe retracted or pushed into the housing 314 of the applicator assembly216. In FIG. 10J, as the applicator assembly 216 is further advancedinto the container 206 along the longitudinal axis Z (FIG. 10F), sleeveunlock features contact and bend the sleeve lock arms 1016 clear of thesleeve lock ledge 1018 thereby unlocking the applicator assembly 216.Note that in the particular example embodiment depicted in FIGS. 10I and10J, the sleeve lock ledge 1018 is formed in a carrier 1022 of theelectronics assembly 310.

When the platform 418 bottoms-out in the container 206 as shown in FIG.10J, the sleeve 318 of the applicator assembly 216 is fullyunlocked/released and ready to move. Note that while the sleeve lockarms 1016 are shown flexing outward to unlock, in some embodiments, thesleeve lock arms 1016 can be oriented to flex radially inward to freethe elements. The same may hold true for the various locking/unlockingfeatures of the present invention. However, the present arrangementoffers advantages in terms of a coordinated whole providing anadvantageous form factor and minimized container casing size (a factorthat affects the user experience) in which the carrier 1022 of theelectronics assembly 310 is coaxially arranged. Regarding the carrier1022, it is advantageously designed with unique carrier arm features asdetailed in, for example, U.S. patent application Ser. No. 13/071,461,the disclosure of which is incorporated herein by reference.

In FIGS. 10K and 10L, now that the sleeve 318 of the applicator assembly216 is fully unlocked, the momentum along the longitudinal axis Z (FIG.10F) from the force used to overcome the resistance of the detentfeatures 1006 (FIG. 10H) causes three additional concurrent actions.First, even though the sleeve 318 cannot descend any further into thecontainer 206 (since it is in contact with the platform 418 which isbottomed-out), the housing 314 of the applicator assembly 216, thecarrier 1022, and the electronics assembly 310 are free to continue todescend into the container 206, now that the sleeve 318 is unlocked asshown in FIG. 10L.

Second, as the electronics assembly 310 descends further along thelongitudinal axis Z (FIG. 10F), the sensor assembly 410 is forced intoan opening in the electronics assembly 310 which couples the sensor tothe electronics and completes assembly of the on-body device 222 (FIG.2F). In some embodiments, mating snap features on the sensor assembly410 and the electronics assembly 310 can be used to compel thecomponents to remain locked and compressed together to insure a sealed,reliable connection. As an alternative to mating snap features, in someembodiments, the sensor assembly 410 and the electronics assembly 310may be coupled by a light press fit or other connection method. However,the positive interaction and lock of snap features is an advantage. Sotoo is the minimal force used to deflect fine locking features thatspring back for engagement.

Third, along with the housing 314, the carrier 1022, and the electronicsassembly 310, a sharp retraction assembly 1024 also continues to descendinto the container 206 along the longitudinal axis Z (FIG. 10F) and isforced to receive the sharp boss 1014 of the sensor assembly 410. Theconical head of the sharp boss 1014 is pushed past a radial arrangementof flexible arms 1026 of the sharp retraction assembly 1024. Theflexible arms 1026 bend outwardly, as they are forced to ride againstthe passing conical surface of the head of the sharp boss 1014. Thesharp is thus thereby engaged by the sharp retraction assembly 1024 asthe flexible arms 1026 snap back into place once the head of the sharpboss 1014 has passed by, securely grasping the head at the narrowed neckportion of the sharp boss 1014. Note that a base of the sharp boss 1014may be included to limit insertion into the sharp retraction assembly1024 through interference with a stop limit or shoulder of the flexiblearms 1026. FIG. 10K illustrates the arrangement immediately before theabove three actions have completed and FIG. 10L illustrates theresulting arrangement immediately after the actions have completed.

In some embodiments, the connection features between the sharp boss 1014of the sensor assembly 410 and the sharp retraction assembly 1024 can beotherwise configured. For example, the sharp retraction assembly 1024can include a conical channel formed from a radial arrangement ofinwardly biased flexible finger members configured to receive the headof sharp boss 1014 such that once the head has passed through thechannel, the flexible fingers conform to the narrowed neck of the sharpboss 1014. With the fingers so conformed, the sharp boss 1014 iscaptured by the sharp retraction assembly 1024. Retention force islimited only by material strength because the self-energizing lock isnot prone to slip between the pieces.

Turning to FIG. 10M, a slightly rotated view, relative to FIG. 10L, isshown. When the sharp boss 1014 is engaged in the sharp retractionassembly 1024, the sensor assembly 410 is coupled to the electronicsassembly 310 completing assembly of the on-body-device 222, and thesleeve 318 is unlocked, platform locking arms 504 and detent arms 1008have engaged undercut grooves 1028 in the container 206, thereby lockingthe platform 418 in the casing 404. This engagement between the platform418 and the casing 404 marks the final position of the container 206from which the loaded applicator assembly 216 is withdrawn for use toapply the on-body device 222 to the user.

Now, once removed from the container 206, the applicator assembly 216 isready to “fire” as illustrated in FIG. 10N. As such, the applicatorassembly 216 is ready to use as in application 108 described inconnection with FIG. 2E. Here, the applicator assembly 216 has alreadybeen unlocked by interaction with the container 206, and the sensorassembly 410 is coupled to the electronics assembly 310. The sharp 1030extends from the on-body device 222 which is held in the sleeve 318 ofthe applicator assembly 216 as shown.

FIGS. 11A to 11F illustrate example details of embodiments of theinternal device mechanics of “firing” the applicator assembly 216 toapply the on-body device 222 to a user and including retracting thesharp 1030 safely back into the used applicator assembly 216. Alltogether, these drawings represent an example sequence of driving thesharp 1030 (supporting a sensor coupled to the on-body device 222) intothe skin of a user, withdrawing the sharp while leaving the sensorbehind in operative contact with interstitial fluid of the user, andadhering the on-body device to the skin of the user with an adhesive.Modification of such activity for use with the alternative applicatorassembly embodiments and components can be appreciated in reference tothe same by those with skill in the art.

Turning now to FIG. 11A, a sensor 1102 is supported within sharp 1030,just above the skin 1104 of the user. Rails 1106 (optionally three ofthem) of an upper guide section 1108 may be provided to controlapplicator assembly 216 motion relative to the sleeve 318. The sleeve318 is held by detent features 1110 within the applicator assembly 216such that appropriate downward force along the longitudinal axis of theapplicator assembly 216 will cause the resistance provided by the detentfeatures 1110 to be overcome so that the sharp 1030 and on-body device222 can translate along the longitudinal axis into (and onto) the skin1104 of the user. In addition, catch arms 1112 of carrier 1022 engagethe sharp retraction assembly 1024 to maintain the sharp 1030 in aposition relative to the on-body device 222.

In FIG. 11B, user force is applied to overcome or override detentfeatures 1110 and sleeve 318 collapses into housing 314 driving theon-body device 222 (with associated parts) to translate down asindicated by the arrow L along the longitudinal axis. An inner diameterof the upper guide section 1108 of the sleeve 318 constrains theposition of carrier arms 1112 through the full stroke of thesensor/sharp insertion process. The retention of the stop surfaces 1114of carrier arms 1112 against the complimentary faces 1116 of the sharpretraction assembly 1024 maintains the position of the members withreturn spring 1118 fully energized.

In FIG. 11C, sensor 1102 and sharp 1030 have reached full insertiondepth. In so doing, the carrier arms 1112 clear the upper guide section1108 inner diameter. Then, the compressed force of the coil returnspring 1118 drives angled stop surfaces 1114 radially outward, releasingforce to drive the sharp carrier 1120 of the sharp retraction assembly1024 to pull the (slotted or otherwise configured) sharp 1030 out of theuser and off of the sensor 1102 as indicated by the arrow R in FIG. 11D.

With the sharp 1030 fully retracted as shown in FIG. 11E, the upperguide section 1108 of the sleeve 318 is set with a final locking feature1120. As shown in FIG. 11F, the spent applicator assembly 216 is removedfrom the insertion site, leaving behind the on-body device 222, and withthe sharp 1030 secured safely inside the applicator assembly 216. Thespent applicator assembly 216 is now ready for disposal.

Operation of the applicator 216 when applying the on-body device 222 isdesigned to provide the user with a sensation that both the insertionand retraction of the sharp 1030 is performed automatically by theinternal mechanisms of the applicator 216. In other words, the presentinvention avoids the user experiencing the sensation that he is manuallydriving the sharp 1030 into his skin. Thus, once the user appliessufficient force to overcome the resistance from the detent features ofthe applicator 216, the resulting actions of the applicator 216 areperceived to be an automated response to the applicator being“triggered.” The user does not perceive that he is supplying additionalforce to drive the sharp 1030 to pierce his skin despite that all thedriving force is provided by the user and no additional biasing/drivingmeans are used to insert the sharp 1030. As detailed above in FIG. 11C,the retraction of the sharp 1030 is automated by the coil return spring1118 of the applicator 216.

As for further details of the operation, alternative embodiments may beappreciated in view of related approaches discussed below, others inreview of the incorporated subject matter and still more appreciated bythose with skill in the art based upon further review of the figureswhich depict actual hardware produced according to various aspects ofthe subject disclosure.

Turning to FIGS. 12A to 12D an alternative applicator/container setapproach is now described. As shown in FIG. 12A, the container 1200holds the electronics assembly 1202. This is in contrast to the aboveembodiments wherein the relationship between the sensor assembly and theelectronics assembly was reversed. Upon aligning markers M and M′, theapplicator 1204 is inserted in the container 1200. In FIG. 12B, theunits are merged. In FIG. 12C, the parts are separated. Finally, in FIG.12D the applicator 1204 is unlocked (e.g., in some embodiments bytwisting the sleeve 1206 within the applicator 1204, in some embodimentsby the act of loading the electronics assembly 1202 into the applicator1204, or in some embodiment by the act of removing a locking strip fromthe sleeve 1206) and ready for use with the assembled on-body device(not visible) including the sensor assembly loaded therein. Thesevarious alternative embodiments are illustrated in FIG. 13A to 15F.

FIGS. 13A to 13C variously illustrate use of the applicator 1204 ofFIGS. 12A to 12D in connection with a locking-sleeve feature 1206. FIG.13A shows the sleeve 1206 locked as indicated by the closed window 1208.After twisting the sleeve 1206 relative to the rest of the applicator1204 to unlock the sleeve 1206, a visual indication (e.g., open window1208′) is seen when the applicator 1204 is ready for use as presented inFIG. 13B. Upon use, as shown in FIG. 13C, the unit is compressed withthe sleeve 1206 collapsed into the applicator 1204.

FIGS. 14A and 14B illustrate an alternative applicator 1400 embodimentwith a removable locking strip 1402. With the locking strip 1402 inplace around the sleeve 1406, the sleeve 1406 cannot be pushed into theapplicator 1400. The strip 1402 includes a pull-tab 1404 and adhesive orother fastening member to keep it in place until removed and theapplicator 1400 is ready for use.

FIGS. 15A to 15F illustrate preparation of the applicator 1400 of FIGS.14A and 14B for use with a container 1500. Once the cover 1502 has beenremoved from the container 1500 and the cap 1506 removed from theapplicator 1400, the applicator 1400 is inserted into container 1500 toload the electronics assembly 1504 into the applicator 1400 and mate thesensor assembly (not shown) with the electronics assembly 1504 as shownin FIGS. 15B and 15C. Once loaded, the applicator 1400 is removed fromthe container 1500 as shown in FIG. 15D. FIG. 15E shows the applicator1400 loaded with the assembled on-body device 222 and ready forsensor/sharp insertion. The locking strip 1402 is removed from thesleeve 1406 and the open ready indicator 1208′ signals that theapplicator 1400 is ready to be used. FIG. 15F illustrates the systemafter such action has been taken in transferring the on-body device 222from the applicator 1400 onto the skin of a user.

FIGS. 16A and 16B are sectional and detail views, respectively, offeatures of the container 1500 in FIGS. 15A-15F. Specifically, theon-body device 1604 is shown in the container 1500 with an adhesivepatch 1602 and its backing 1606. The backing 1606 is spiral-cut andattached to a boss so that when the on-body device 1604 is transferredfrom the container 1500, the peel-away backing 1606 is left behind. Inthis fashion, the adhesive patch 1602 remains covered by the backing1606 so it does not inadvertently adhere to the container 1500.

As an alternative to the spiral peel-around backing approach of FIGS.16A and 16B, FIGS. 17A and 17B are perspective assembly viewsillustrating alternative container 1702 configurations for capturingseparate peel-off “butterfly” wings or bilateral liner panels from theadhesive-backed patch of the on-body device 1706. In each case, atwo-part base 1704 is provided for gripping the peel-away backing linerpieces. Naturally, the base 1704 is adapted to fit in the containercasing. In some embodiments, the container 1702 can be configureddifferently. In the version depicted in FIG. 17A, traction/tread 1708 isprovided to assist with grip of the backing. In the version depicted inFIG. 17B, ramps 1710 are provided to assist in removing the backing. Inanother version, the base can be a one-piece molding incorporating aliving hinge in a “clamshell” arrangement. The backing liner piece(s)may be captured along a center line or at an offset location. Howeverconfigured, the base 1704 may snap into place with complementary bandand rib interface features associated with each of the base 1704 andcontainer 1702, snaps, or other features. As with other assembliesdescribed herein, these features may alternatively be press fit,ultrasonically welded or otherwise secured in place.

FIG. 18 is a cross-sectional view illustrating features of theapplicator and container sets shown in FIGS. 15A-15F. The embodimentshown in FIG. 18 includes several of the features described inconnection with the alternative loading approach above. However, it issimplified in approach. Most notably, the container 1806 includes noactive/mobile components. Once the applicator 1800 is pressed down intothe container 1806, the on-body device 1808 is assembled (e.g., thesensor assembly is mated with the electronics assembly), released fromthe container 1806 (e.g., using releasable latches), and held by theapplicator 1800 (e.g., using latching arms). This embodiment offers anadvantage of not having to expose the adhesive of the on-body device1808 as in other embodiments. Furthermore, the position of the on-bodydevice 1808 provides a stable surface for the sensor assembly insertion.Other embodiments where the applicator is pre-loaded with the on-bodydevice do provide the advantage of not having to perform theabove-described hand-off Also, the use or inclusion of a protector forthe sharp is avoided.

FIGS. 19A and 19B show a sensor assembly 1902 in association with aneedle guard 1904. In use, a distal interface feature (e.g., a barb) ofthe needle guard 1904 is captured by a complimentary split ring or otherfeature in the container during the assembly of the on-body device.Then, when the applicator is separated from the container, the needleguard 1904 is retained in the container and the sharp is unsheathed. Insome embodiments, the needle guard 1904 may be made from polypropylenewith a thermoplastic elastomer (TPE) insert to releasably secure thesharp. Other materials may be selected.

Other materials may be selected for construction of other elements ofthe present invention. For example, the applicator housing may be madeof polycarbonate or any other practicable material. The guide sleeve,container, etc. may be constructed from acetyl (for reason of lubricityof sliding parts). Any number of the parts may be injected molded,thermoformed or otherwise produced.

Regarding the sensor assembly hand-off to the electronics assembly,FIGS. 20A and 20B illustrate a manner of holding a sensor assembly boss2006 to the element 2002 that will pick up the electronics assembly 2004to form the on-body device. Spring armatures 2008 clip to a lip of thesensor assembly 2006 and hold the sensor assembly 2006 within theapplicator during shipping and handling. When the applicator and thecontainer are brought together, lever arms 2010 contact the on-bodydevice 2004, causing the associated spring armatures (or “spring arms”)to twist and rotate the connection away from the lip of the sensorassembly, thereby releasing the sensor assembly. A chamfer on the sensorassembly boss can help ensure alignment and proper actuation of the oneor more (e.g., three) torqueing spring armatures 2008.

FIGS. 21A-21C illustrate an alternative hand-off approach. In thisembodiment, a sensor assembly gripper 2106, with a light snap fit, grabsand orients the sensor assembly 2104 for connection to the electronicsassembly 2102. After the sensor assembly 2104 is firmly snapped into theelectronics assembly 2102, the sensor assembly gripper 2106 is retractedwith an amount of force that overcomes its grip. Such an approach offerssimplicity by reducing the number of parts required (given that the snapfeatures may be incorporated in the sharp hub/boss).

Electrical Connections Details

The selection of various hardware options from the above alternativeembodiments will depend, at least in part, on the sensor assemblyconfiguration. Sensor assembly configuration, in turn, depends on themechanism selected for establishing electrical contact between thesensor assembly and the electronics assembly, as well as the method usedto seal the contacts. A number of advantageous alternative embodimentsare illustrated in FIGS. 22 through 48.

A first example is presented in FIG. 22. Here a sensor 2202 is providedwith an elongate “tail” section. The distal portion of the tail is to beinserted through the skin surface guided by a sharp. The proximalportion of the sensor 2202 includes a “flag” type connector region.Three carbon-doped (for conductivity) silicone electrical connectors2204 are provided to interface with the electrical contacts of thesensor 2202. A split “V” portion of each connector 2204 receives theelectrical contacts of the sensor 2202. A flexible nubbin on theopposite side of each connector 2204 is provided for electrical contactwith the circuit board incorporated in the electronics assembly. Wheninserted in a housing 2210, the sensor 2202 and the connector 2204 areadvantageously sealed, encased or potted with an adhesive. Epoxy, a UVcure or another type of dielectric (non-conductive) compound may beused. Generally, the compound selected is of such viscosity that it isable to flow around features and fully seal the sensor 2202 within itshousing 2210 to avoid leakage. Such an approach avoids contaminationand/or current leakage due to fluid intrusion. FIGS. 23A and 23B areperspective assembly and final-assembly cross-sectional views,respectively of the sensor components of FIG. 22. The tail of the sensor2202 is supported within the sharp 2206 and the sharp 2206 extendsthrough the connector housing 2210. The electrical contacts of thesensor 2202 are seated in the connector 2204 and the assembly is sealedwithin the housing 2210 including the housing top 2208.

FIGS. 24A and 24B are top and bottom perspective views, respectively ofcircuit board components to be used with the sensor assembly 2300 ofFIGS. 23A and 23B. In each, a custom printed circuit board (PCB) 2402 isshown. The PCB 2402 includes a battery 2406 with mount 2408, anapplication specific integrated circuit (ASIC) 2410, or otherappropriate processing unit, and various other circuitry, including athermocouple. On its face, the PCB 2402 includes a housing 2404 withsnap features for receiving the sensor assembly 2300 of FIGS. 23A and23B. On the reverse side of the PCB 2402, heat stakes 2412 show the modeof attaching the housing 2404.

Turning to FIGS. 25A and 25B, in some embodiments, the on-body device2502 is formed by over molding with a polymer “macromelt” (e.g., athermoplastic hot-melt based on polyamide) or other compound and thenaffixing an adhesive patch with a releasable liner thereto. A completedon-body device 2502 is provided once fitted with a complimentary sensorassembly 2300, as illustrated in FIGS. 25A and 25B. Internal to suchassembly, it may be desirable to include a seal or gasket 2604 as shownin assembly view FIG. 26. As shown in cross section, in FIG. 27A, andmagnified in FIG. 27B, the gasket 2604 advantageously includes discretering/rim elements to compress and ensure sealing in critical areas,including around each circuit connection/nubbin.

FIGS. 28A-28F illustrate another advantageous sensor 2802 and sensormount or connector 2804 arrangement. This embodiment resembles theprevious approach, but is configured with a bend and a curve imparted tothe sensor connection “flag.” This permits package and sealing within ina roughly triangular envelope to shorten the length of the connector.Doing so results in a generally more compact sensor assembly body andthe ability to downsize all associated components. Yet, it does notsignificantly complicate manufacture. FIG. 28A depicts the sensor 2802before it is shaped to fit within the connector 2804. FIG. 28B depictsthe bent and curved sensor connection “flag.” FIG. 28C depicts therelative orientation of the sensor 2802 as it is inserted into theconnector 2804. FIG. 28D depicts a wedge 2806 that is press-fit into theconnector 2804 to retain the sensor 2802 and press the connector'selectrical contacts against the electrical contacts of the sensor 2802.FIG. 28E depicts the relative orientation of the sharp 2808 as it isinserted into the connector 2804 and FIG. 28F depicts the completedsensor assembly including potting 2810 (e.g., UV potting) used to sealthe electrical contacts.

An alternative embodiment is contemplated in connection with the sensorapproach illustrated in FIGS. 29A-29D. Using a sensor 2902 with avertically disposed “flag” connector portion that is supported bycoupling 2904, coupling 2904 is configured to snap into connector block2908 which is attached to PCB 2914. Connector block 2908 includes aconnector socket 2910 to receive the contacts portion of the sensor2902. Connector block 2908 also includes a coupling feature 2912 toreceive snap-fit tab 2906 on the coupling 2904 which retains the sensor2902 in the connector socket 2910.

Another alternative embodiment is contemplated in connection with thesensor approach illustrated in FIGS. 30A-30C. Here, a design is providedthat eliminates a connection element and the need for separate springcontacts (be they metal or elastomeric as above). In addition, theapproach offers the advantage of effectively converting a sensor withcontacts on two sides into a sensor with contacts on a single side afterfolding. The sensor 3004 shown in FIG. 30A initially has two electricalcontacts facing a first direction on the split contact area and onecontact facing in a second, opposite direction (obscured by the view).When folded and optionally clamped, glued or otherwise affixed in theorientation shown in FIG. 30B, all of the electrical contacts lie in asingle plane, facing the same direction (e.g., downward in the drawing).Set within a housing (not shown) to restrain and/or seal the sensor3004, the sensor 3004 is coupled to electrical contacts on the PCB 3002as shown in FIG. 30C.

Such an approach in some embodiments includes a thinner (e.g., lowerprofile) on-body device relative to the on-body device 3102 variationshown in FIG. 31. The reduced thickness dimension is represented byheight H. In FIG. 31, a flag type sensor is shown in a housing withseparate electrical connectors. The “stack height” in FIG. 31 includesthese connectors as well as the housing. The approach shown in FIG. 30enables eliminating the connector height above the sensor 3004. Thus,elements are eliminated without losing functionality. Moreover, theelimination of parts reduces cost, and impedance (relative at least tothe inclusion of elastomeric connectors as shown in FIG. 22, etc.)between the sensor 3004 and the PCB. Another useful aspect is allowing asensor with contacts on two sides to connect to the PCB withoutrequiring vias or holes in the sensor, thereby helping with sealingconsiderations and ease of electrical connection.

FIGS. 32A and 32B illustrate two additional sensor configurations. Inthese embodiments, sensors 3202, 3212 with contacts on two sides aresplit and bent in opposite directions to orient the electrical contacts3204, 3214 onto a single face or plane. As above, orienting theelectrical contacts 3204, 3214 onto a single plane facilitates ease ofsealing the electrical connections. Moreover, overall sensor assemblyheight can be reduced relative to other approaches. Any of conductiveadhesives, conductive films and/or mechanical contacts may be used toelectrically connect with the sensor contacts so arranged.

FIGS. 33A-33G depict a low-profile multilayer sensor configuration withthe electrical contacts all on one side and some details of itsconstruction. FIGS. 33A and 33B illustrate the two sides of thisembodiment of a sensor 3300 and its overall shape. The example sensor3300 includes a tail portion 3302 that is initially supported by a sharpand then disposed within the user's interstitial fluid or dermal spacebelow the skin upon application of the on-body device. The tail portion3302 includes electrodes 3304, 3306, 3308 that are used to contact theinterstitial fluid and to sense (e.g., transmit and receive) theelectrical signals used to measure the analyte concentration within theinterstitial fluid. The sensor 3300 also includes an electrical contactsportion 3310 which includes electrical contacts 3312, 3314, 3316 thatare disposed all on one side of the sensor 3300 and are in electricalcommunication with the electrodes 3304, 3306, 3308 via conductive traces(not visible in FIGS. 33A and 33B but see FIG. 33F). Note also that theelectrical contacts portion 3310 is shaped to facilitate being securelyheld and sealed into a connector support that will be described below.For example, the electrical contacts portion 3310 includes securementfeatures that hold the sensor to be secured to the connector support byfriction fit, interference fit, etc., herein shown as tabs 3310A andnotches 3310B that allow the electrical contacts portion 3310 to be heldsecurely in the connector support which includes mating features.

The sensor 3300 also includes a bendable portion 3318 that allows theelectrical contacts portion 3310 to be arranged parallel to the circuitboard of the electronics assembly to facilitate a relatively flat or lowprofile within the electronics assembly. The bendable portion 3318 alsoallows the tail portion 3302 to extend down from the electronicsassembly so that it can be inserted below the skin of the user while theelectrical contacts portion 3310 lays parallel to the circuit board.Lastly, the sensor 3300 includes an armature portion 3320 that allowsthe sensor 3300 to be held securely to the connector support of thesensor assembly. The armature portion 3320 also provides a leveragepoint to apply a biasing force to compel the tail portion 3302 into achannel of the sharp as described below in FIG. 35D and the associatedtext.

FIG. 33C depicts a side view of the sensor 3300. The encircled portionlabeled D is shown in more detail in FIG. 33D. FIG. 33D provides amagnified side view of the distal most part of the tail portion 3302 ofthe sensor 3300. The encircled portion labeled E is shown in more detailin FIG. 33E. FIG. 33E provides an even further magnified view of theelectrodes 3304, 3306, 3308 of the tail portion 3302. As can be seen inFIG. 33E, the electrodes 3304, 3306, 3308 are formed as layers on asubstrate 3322. The substrate 3322 is made of a flexible, non-conductivedielectric material. In some embodiments, a clear, high-gloss, heatstabilized polyester film may be used for the substrate 3322 andconductive carbon ink can be used to create the trace layers used forthe electrodes 3304, 3306, 3308. In other embodiments, other materialsmay be used for the substrate 3322 such as polymeric or plasticmaterials and ceramic materials and for the trace layers such as carbonor gold.

Dielectric layers 3324, 3326, 3328 are disposed between and upon theelectrodes 3304, 3306, 3308 to insulate the electrodes 3304, 3306, 3308from each other. In some embodiments, an ultraviolet (UV) light curabledielectric material may be used for the dielectric layers 3324, 3326,3328. In other embodiments, other practicable materials may be used. Inthe particular example embodiment shown, electrode 3304 is a counterelectrode, electrode 3306 is a working electrode, and electrode 3308 isa reference electrode. Note that reference electrode 3308 also includesa secondary conductive layer 3330, e.g., an Ag/AgCl layer. In certainembodiments, the lateral surface of the secondary conducive layer 3330is covered by a dielectric layer 3328 resulting in only the side edgesthe secondary conductive layer 3330, which extend along the side edgesof the substrate 3322, being uncovered by dielectric layer 3328 and, assuch, are exposed to the environment when in operative use. In suchembodiments, dielectric layer 3328 covers the entire lateral surface ofthe secondary conducive layer 3330, i.e., 100% of the lateral surface ofthe secondary conducive layer 3330 is covered by dielectric layer 3328.As such, dielectric layer 3328 has at least the same lateral width andat least the same length as conductive layer 3330.

Further details of the arrangement, dimensions, chemistry, andmanufacturing methods of the sensor 3300 may be found in U.S. patentapplication Ser. No. 13/526,136, entitled “Connectors For MakingConnections Between Analyte Sensors And Other Devices,” which was filedJun. 18, 2012, and which is incorporated by reference herein in itsentirety and for all purposes.

FIG. 33F depicts a view of the sensor 3300 of FIGS. 33A and 33Bincluding hidden lines representing different layers of electricallyconductive trace lines 3332, 3334, 3336 connecting the electricalcontacts 3312, 3314, 3316 to the electrodes 3304, 3306, 3308. Theelectrical contacts 3314, 3316 for the electrodes on the opposite sideof the sensor 3300 are coupled to the respective conductive traces 3334,3336 using vias 3338, 3340 (only two labeled). FIG. 33G is across-sectional view of the sensor 3300 taken along line GG of FIG. 33F.As can be seen, conductive trace 3332 covered by dielectric layer 3324is on one side of the substrate 3322 while conductive traces 3334, 3336separated by dielectric layer 3326 and covered by dielectric layer 3328is on the opposite side on the substrate 3322. The electrical contacts3314, 3316 are accessible via openings in the dielectric layer 3328.

FIGS. 33H to 33J depict three alternative sensor designs 3342, 3344,3300 side by side for comparison. Notably sensor 3342 includes anaperture 3346 to receive a rivet or other fastener for physicalattachment to the PCB of the electronics assembly. Details of sensor3342 are provided in previously incorporated U.S. patent applicationSer. No. 13/526,136, entitled “Connectors For Making Connections BetweenAnalyte Sensors And Other Devices,” which was filed Jun. 18, 2012.Sensors 3344 and 3300 are suitable for use with the alternativeconnector arrangements described below with respect to FIGS. 34A-35D.

Turning now to FIGS. 34A-35D, an alternative connector arrangement forconnecting a circuit board to a sensor 3300 such as depicted in FIGS.33A, 33B, and 33J is described. As shown in FIG. 34A, a flexibleone-piece seal or connector 3402 is molded in silicone or otherpracticable elastic material. Separate doped silicone conductiveelements are set therein which provide electrical contacts 3410 forconnection to a circuit board. In some embodiments, the conductiveelements can alternatively be over molded or insert-molded into place.The result is a generally malleable/flexible hybrid connection andsealing unit or connector 3402 incorporating a living hinge joining two(as-shown) symmetrical sections. Alternatively, a two-piece design ispossible. Yet, with the unitary design, the arrangement can be neatlysecured using a single catch boss or post 3412 opposite the hingedsection. In some embodiments, two or more posts can be used to securethe connector 3402 folded around and sealing both sides of the contactsportion of the sensor 3300. Thus, even if a dielectric coating on thesensor 3300 fails (e.g., pinhole leaks), the connector 3402 insures thatthe sensor contacts 3312, 3314, 3316 are protected from moisture or anycontaminants. The one-piece design also facilitates assembly asillustrated, in which the flexible connector 3402 is set in a rigid orsemi-rigid housing or connector support 3404 with one side located onthe post 3412. Then a sensor 3300 is inserted, and bent approximatelyninety degrees at the bendable portion 3318 of the sensor 3300. Oncebent, the sensor 3300 is then captured with the upper part of theconnector 3402 by folding over the connector 3402 as indicated by arrowS in FIG. 34C. The connector 3402 is illustrated as bilaterallysymmetrical, however, the connector 3402 can be formed in adirection-specific orientation because in some embodiments, certain ofthe electrical contacts 3410 may not be necessary. In some embodiments,all the sensor's electrical contacts 3312, 3314, 3316 can be provided ona single side of the sensor 3300 or, in other embodiments, both sides ofthe sensor 3300.

As shown in FIG. 34D, in some embodiments, the top surface of theconnector 3402 includes a raised lip 3418 disposed at the top surfaceedge of the connector 3402 that encircles the electrical contacts 3410of the connector 3402. The raised lip 3418 can be integrally formed inthe elastomeric material that forms the connector 3402 and is thuscompressible when the sensor assembly is inserted into the electronicsassembly. Alternatively, the raised lip can be embodied as gasket orO-ring on the top surface of the connector 3402. The raised lip 3418functions to ensure that a seal is formed around the electrical contacts3410 of the connector 3402 and the electrical contacts of the PCB beforeany electrical connectivity between the sensor and the electronicsassembly is established. Thus, the raised lip 3418 provides a failsafeagainst a short by ensuring the order of assembly includes creating aseal and then creating electrical connectivity as the sensor assembly ismated with the electronics assembly.

In any case, with the sensor 3300 captured within the seal 3402, a sharp3408 is then introduced, with its hub 3414 contacting the connectorsupport 3404 as shown in FIG. 34D. FIG. 35A illustrates the orientationof the sharp 3408 prior to the insertion of the sharp 3408 into theconnector support 3404. FIGS. 35B and 35C provide a cross-sectionaloverview of the relationship of the sharp 3408 to the sensor 3300.Notably, once inserted in the connector support 3404, the sharp 3408surrounds and supports the tail portion 3302 of the sensor 3300. In FIG.35D, further details of the sensor configuration are visible.Particularly, biasing features are shown that abut surfaces of theconnector support 3404 in order to center and bias the sensor 3300 intothe channel of the sharp 3408. Specifically, armature portion 3320 abutsthe surface at arrow 3502 of the connector support 3404 which causes thebiasing feature 3508 to act as a fulcrum at arrow 3504 to push the tailportion 3302 of the sensor 3300 into the sharp 3408 at arrow 3506.

In some embodiments, the curved section 3508 of the sensor 3300 canoverlie a corresponding surface of the connector support 3404 to helplimit the insertion depth (i.e., provide a depth stop) for the sensor3300. Sensor 3300 vertical placement, including insertion depth, is alsocontrolled based on the relationship between the seal 3402 halves. Asnoted with respect to the other sensor assembly housings/supportsdiscussed herein, the sensor assembly of FIG. 35C can also includevarious clip or snap features for its precise associations with a socketin the electronics assembly within the on-body device.

A related arrangement to that described in connection with FIGS. 34A-34Dand 35A-35D is presented in FIGS. 36 to 38. In FIG. 36, a sensor 3300with all electrical contacts on the same side is shown with a sharp 3602for insertion in a connector support 3604. The connector support 3604includes an elastomeric (e.g., silicone) seal backing. Once such asensor assembly set is in a container (or alternatively in anapplicator), the sensor assembly can be coupled to the sensorelectronics to form an on-body device 222. As shown in FIG. 37, thesensor assembly 3702 is shaped to fit within a socket 3704 that includesa second elastomeric unit with electrical contacts in the elastomer bodyof the socket 3704. Note that in FIG. 37, the enclosure of theelectronics assembly is not shown so that the socket can be more clearlydisplayed. The socket 3704 is affixed to a circuit board 3706 via anypracticable method. The socket 3704 and/or the connector support 3604can include various coupling features (e.g., a snap fit lip and hookarrangement) to ensure that the electrical contacts are pressed tightlytogether and sealed within the socket 3704 and sensor assembly 3702.Once the sensor assembly 3702 is received within the socket 3704, theon-body device (e.g., with the complete over-mold enclosure around thecircuit board 3706 and adhesive patch 3802 as shown in FIG. 38) is readyfor use.

The electrical contacts/connector approaches described above are“directional.” In other words, before the sensor assembly is mated withthe electronics assembly, the two are aligned relative to each otherboth longitudinally and rotationally. In some embodiments, the couplingarrangement is “non-directional” and the sensor assembly can be matedwith the electronics assembly without aligning the two rotationally. Forexample, the sensor assembly construction shown in FIGS. 39A and 39Boffers such an approach. Separate conductive (e.g., optionally metal)bands 3904 mounted on a core support 3906 connect to sensor electricalcontacts 3908 as shown in FIGS. 39A and 39B. The assembled unit (i.e.,the sensor assembly 3910), with sharp 3902 in place, is received in thesocket of an electronics assembly 4002 to form an on-body device asillustrated in FIG. 40. In some embodiments, brush-type connectors 4004on the circuit board in the electronics assembly 4002 reach up to theindividual levels of the conductive bands 3904. Such a sensor assembly3910 can be inserted into the socket of the electronics assembly 4002 inany radial/rotational orientation.

A “reversed” approach is illustrated in the sensor assembly 4100 ofFIGS. 41A-41C. Here, the circuit board 4102 includes a socket connector4104 that has an arrangement of stacked conductive elastomeric O-rings4106 disposed within the inner diameter of the socket connector 4104. Asensor support 4108 is adapted to hold the electrical contacts 4110 ofthe sensor 4112 in a corresponding stack facing radially outward. Whenthe sensor support 4108 is inserted into the socket connector 4104, theconductive elastomeric O-rings 4106 align vertically with the electricalcontacts of the sensor as shown in FIG. 41B (with the socket connector4104 not shown so that the conductive elastomeric O-rings 4106 are moreclearly visible) and in the cross-sectional view of FIG. 41C. In someembodiments, the electrical contacts 4110 of the sensor 4112 can beformed by rolling up a sensor with contacts all on the same side orusing the oppositely directed folding/rolling approach shown inconnection with FIG. 40—but oriented vertically. Other approaches may beutilized as well. In any case, the electrical contacts of the sensorsubtend less than 360 degrees while the conductive elastomeric O-ringson the circuit board provide a multi-level encircling relationship. Aswith the approach associated with FIGS. 39A to 40, such a sensorassembly 4100 can be inserted into the socket connector 4104 of theelectronics assembly 4102 in any radial/rotational orientation.

The sensor connections associated with the circuit board 4404 in theembodiment shown in FIGS. 42 to 44 are arranged in concentric rings. Thesensor 4202 includes electrical contacts 4204 held within housing member4206 and base 4208. The electrical contacts 4204 include “micro-spring”wireform connectors. These springs provide compliance as well as adiscrete top loop. Each electrical contact 4204 is disposed at adifferent radial distance from the center corresponding to a differentconcentric conductive track 4304 on a circuit board coupling 4302. Thus,no matter the rotational orientation of the sensor assembly 4200relative to the circuit board coupling 4302, the electrical contacts4204 of the sensor 4202 align with the correct concentric conductivetracks 4304. Very fine wire can be used for the springs, thus producingan easily miniaturized system.

Turning now to FIGS. 45A and 45B, another non-directional sensorassembly connection approach that can be employed with a concentricelectronics assembly connection is depicted. As illustrated in theisometric top and bottom views of FIGS. 45A and 45B, a sensor 4504 bentapproximately ninety degrees with contacts positioned along differentradial paths or arcs, connects with conductive elastomeric contacts 4508supported by two opposing discs 4502, 4506. Two of the elastomericcontacts 4508 are set on one disc 4506, and a third, configured to passthrough a sensor via, is set on the other disc 4502. As shown in FIG.46A, this sensor assembly 4500 can then be received by a circuit boardcoupling 4604 which includes concentric tracks for connecting theradially disposed conductive elastomeric contacts 4508 of the sensorassembly 4500 to the circuit board 4606. The enclosure 4608 snap fits oris otherwise adhered to (e.g., using adhesive/welding) a base supportingthe circuit board 4606. The as-assembled on-body device 4600 is depictedin FIG. 46B.

Turning now to FIGS. 47A to 47C, an alternative sensorassembly/electronics assembly connection approach is illustrated. Asshown, the sensor assembly 4702 includes sensor 4704, connector support4706, and sharp 4708. Notably, sensor assembly 4702 does not include aseparate connector or seal to enclose the sensor's connectors within theconnector support 4706 as in the embodiment depicted in FIGS. 34A to 34D(i.e., no seal 3402). Instead, a recess 4710 formed directly in theenclosure of the electronics assembly 4712 includes an elastomericsealing member 4714 (including conductive material coupled to thecircuit board and aligned with the electrical contacts of the sensor4704). Thus, when the sensor assembly 4702 is snap fit or otherwiseadhered to the electronics assembly 4712 by driving the sensor assembly4702 into the integrally formed recess 4710 in the electronics assembly4712, the on-body device 4714 depicted in FIG. 47C is formed. Thisembodiment provides an integrated connector for the sensor assembly 4702within the electronics assembly 4712.

On-Body Device Construction Details

Certain elements of the on-body device fabrication may apply to any orall of the above electrical connection configurations. FIGS. 48A-48Dprovide top (FIG. 48A) and bottom (FIG. 48B-48D) construction views ofan exemplary on-body device subassembly. A socket 4802 or mount is fitthrough vias in a printed circuit board 4800 along with other associatedcomponents including a processor 4804 (e.g., an ASIC including acommunications facility), thermistor/thermocouple 4806, a battery mount4808, etc. Once the circuit board 4800 has been populated with thesecomponents as shown in FIG. 48C, the socket 4802 is adhered to thecircuit board 4800 (e.g., using heat stakes). Once a battery 4810 is setin place, the circuit board 4800 as shown in FIG. 48E is prepared forincorporation into an on-body device.

The circuit board 4800 is ready for an over-mold process or othersealing method. As illustrated in FIGS. 49A-49D, the circuit board 4800is first set in the two-piece mold 4902, 4904. With the mold slide 4906inserted and mold 4902, 4904 closed as shown in FIG. 49B. As depicted inFIG. 49C, a thermoplastic material is injected into the mold 4902, 4904,encasing the circuit board 4800. The mold 4902, 4904 is opened and thenear-final part ejected as shown in FIG. 49D.

Alternatively, the enclosure of the electronics assembly of the on-bodydevice 222 may include elements snap-fit (or welded/adhered) together asillustrated in the assembly view of FIG. 50A, the as-assembled view ofFIG. 50B, and in cross-sectional perspective view of FIG. 50C. Anenclosure including a top shell 5002 and a mounting base 5004 can beused to sealably enclose and protect the circuit board 4800. Whensnap-fit, various interference or snap fit elements (e.g., annular rims5006) may be provided around the entirety of the periphery of theenclosure or as discrete snap-fit connectors (not shown). Notably, suchan approach may benefit from additional O-ring sealing elements to avoidfluid intrusion. Alternatively or additionally, adhesive set at the snapjunction(s) may be used to ensure good sealing, especially in connectionwith continuous annular snap-fit features 5006. As seen in FIG. 50C, atrough 5008 or other features can be provided to insure that adhesive5010 that may be squeezed out during assembly is not forced into areasthat could interfere with operation or assembly of the on-body device222. In some embodiments, when a top shell 5002 and a mounting base 5004are fit together with a bead of adhesive 5010 in place as shown, thetrough 5008 not only provides space to capture the adhesive 5010squeezed out but also provides additional surface area for a thickerlayer of adhesive 5010 to seal the joint.

However constructed, final assembly of the electronics assembly ofon-body device 222 involves adhesive patch installation. An exemplaryapproach is illustrated in FIGS. 51A-51C. First, a double-sided adhesivepatch 5104 has the inner liner 5102 removed. This exposed adhesive isset over the on-body device body 5106 (with the temperature sensor 4806folded to seat within a complimentary pocket) and adhered with a firstwindow 5108 aligned for temperature sensing and second window 5110 forsensor assembly receipt. As such, it is ready for placement in anapplicator assembly upon removal of the outer release liner, oralternatively ready for placement in a container with or without theouter liner in place, depending on the presence or absence of anyliner-puller features provided therein.

Various other modifications and alterations in the structure and methodof operation of the embodiments of the present disclosure will beapparent to those skilled in the art without departing from the scopeand spirit of the present disclosure. Although the present disclosurehas been described in connection with certain embodiments, it should beunderstood that the present disclosure as claimed should not be undulylimited to such embodiments. It is intended that the following claimsdefine the scope of the present disclosure and that structures andmethods within the scope of these claims and their equivalents becovered thereby.

1-64. (canceled)
 65. An assembly comprising: an applicator comprising asharp; an on-body device comprising: (1) a glucose sensor assemblycomprising: a proximal section comprising a connector support coupledwith a proximal portion of a glucose sensor; and a distal tail sectioncomprising a distal portion of the glucose sensor configured to bepositioned under a skin surface and in contact with a bodily fluid of asubject; (2) a housing comprising: a top portion; a base portionconfigured to be adhered to the skin surface of the subject by anadhesive patch; and a first space defined by the top portion and thebase portion; and (3) sensor electronics positioned within the firstspace, the sensor electronics comprising a processor, a wirelesscommunications facility, a battery, and a printed circuit board, whereinthe base portion of the housing comprises a recess in a bottom exteriorsurface, the recess comprising a distal-facing opening, and wherein therecess defines a second space different from the first space, whereinthe glucose sensor assembly extends through the distal-facing openingand into the recess such that the glucose sensor is electrically coupledwith the sensor electronics by the connector support, wherein thewireless communications facility is configured to communicate dataindicative of a glucose level detected by the glucose sensor to areceiver unit, wherein the on-body device and the sharp are entirelydisposed within an interior of the applicator, wherein the applicator isconfigured to advance the on-body device and the sharp from a firstposition to a second position such that a distal end of the sharppierces the skin surface of the subject and the base portion of thehousing is adhered to the skin surface of the subject, and wherein theapplicator is further configured to automatically retract the distal endof the sharp from within the subject to within the interior of theapplicator.
 66. The assembly of claim 65, wherein the top portion of thehousing comprises an aperture, and wherein a longitudinal insertion axisextends through the aperture and the recess of the base portion of thehousing.
 67. The assembly of claim 66, wherein the housing furthercomprises a side wall, wherein the top portion of the housing comprisesa top exterior surface, and wherein the side wall is located between thetop exterior surface of the top portion of the housing and the bottomexterior surface of the base portion of the housing.
 68. The assembly ofclaim 67, wherein the housing further comprises a plurality ofengagement recesses circumferentially disposed thereon, wherein theplurality of engagement recesses comprises a first engagement recess ina spaced relation to a second engagement recess, and wherein theplurality of engagement recesses is detachably engaged to theapplicator.
 69. The assembly of claim 68, wherein the recess isconfigured to receive the connector support while the sensor electronicsare in the first space.
 70. The assembly of claim 69, wherein theprinted circuit board comprises an aperture, and wherein thelongitudinal insertion axis extends through the aperture of the printedcircuit board.
 71. The assembly of claim 69, wherein the connectorsupport is electrically coupled with the sensor electronics via aninterface that is external to the first space, and wherein the interfaceis disposed within the recess.
 72. The assembly of claim 69, wherein theglucose sensor assembly further comprises a bent section between theproximal section and the distal tail section, wherein the proximalsection and the distal tail section are approximately perpendicular toeach other when the on-body device is in the first position.
 73. Theassembly of claim 69, wherein each of the plurality of engagementrecesses comprises a concave portion.
 74. The assembly of claim 69,wherein each of the plurality of engagement recesses is disposed on theside wall of the housing.
 75. The assembly of claim 69, wherein the sidewall comprises a first portion and a second portion, wherein the firstportion of the side wall is substantially orthogonal to the bottomexterior surface of the base portion of the housing, and wherein thesecond portion of the side wall is non-orthogonal to the top exteriorsurface of the top portion of the housing.
 76. The assembly of claim 69,wherein the connector support comprises a planar surface.
 77. Theassembly of claim 69, further comprising an elastomeric sealing memberdisposed within the recess.
 78. The assembly of claim 77, wherein theelastomeric sealing member is in contact with the connector support. 79.The assembly of claim 69, wherein the adhesive patch is coupled with thebase portion, and wherein the adhesive patch comprises a window alignedwith the distal-facing opening.
 80. The assembly of claim 69, whereinthe sensor electronics comprise a first set of mating features coupledwith a second set of mating features of the glucose sensor assembly. 81.The assembly of claim 69, wherein the recess of the base portioncontains a first set of mating features coupled with a second set ofmating features of the glucose sensor assembly.
 82. The assembly ofclaim 69, wherein the distal-facing opening comprises a polygonalcross-sectional area.
 83. The assembly of claim 82, wherein a shape ofthe connector support of the glucose sensor assembly corresponds withthe polygonal cross-sectional area of the distal-facing opening.
 84. Theassembly of claim 69, wherein the housing comprises a single integralunit.
 85. The assembly of claim 84, wherein the top portion and the baseportion form a single over-molded unit comprising a thermoplasticmaterial, and wherein the single over-molded unit seals the sensorelectronics within the first space.
 86. The assembly of claim 69,wherein the top portion and the base portion are coupled by a snap-fitmechanism such that the sensor electronics are sealed within the firstspace.
 87. The assembly of claim 69, wherein the top portion and thebase portion are welded together such that the sensor electronics aresealed within the first space.
 88. The assembly of claim 69, wherein thetop portion and the base portion are adhered together such that thesensor electronics are sealed within the first space.
 89. The assemblyof claim 70, wherein the sharp extends through the aperture of the topportion of the housing, the aperture of the printed circuit board, andthe recess of the base portion of the housing when the on-body device isin the first position.
 90. The assembly of claim 69, further comprisinga cap removably attached to a distal portion of the applicator by aplurality of threads.
 91. The assembly of claim 69, wherein the sharpextends through the aperture of the top portion of the housing and therecess of the base portion of the housing when the on-body device is inthe first position, wherein the connector support is electricallycoupled with the sensor electronics via an interface that is external tothe first space, and wherein the interface is disposed within therecess, and wherein the glucose sensor assembly further comprises a bentsection between the proximal section and the distal tail section,wherein the proximal section and the distal tail section areapproximately perpendicular to each other when the on-body device is inthe first position.
 92. The assembly of claim 91, wherein thedistal-facing opening comprises a polygonal cross-sectional area, andwherein a shape of the connector support of the glucose sensor assemblycorresponds with the polygonal cross-sectional area of the distal-facingopening.
 93. The assembly of claim 92, wherein the connector supportcomprises a planar surface, wherein the printed circuit board comprisesan aperture, and wherein the sharp extends through the aperture of theprinted circuit board when the on-body device is in the first position.94. The assembly of claim 93, further comprising an elastomeric sealingmember disposed within the recess.